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PiloKit: a prospective, open-label clinical study for the management of haemorrhoids, anal fissures, and perineal wounds
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DOI：10.1016/j.hermed.2025.101078.png)
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Abstract
En 中文
Introduction: This study aimed to evaluate the effect of a 15-day course of PiloKit on symptom severity and symptom-related quality of life in patients with haemorrhoids, fissures, and perineal wounds, compared with placebo and the current standard of care. Methods: This prospective, open-label, single-centre clinical study included 87 patients with haemorrhoids, fissures, or perineal wounds. Participants were assigned to three groups: placebo (diet + Isabgol + exercise, n = 30), regular treatment (anorectal cream + Daflon + Isabgol, n = 27), and PiloKit (n = 30; PiloSpray 2-3 times daily, PiloTab 1 tablet twice daily, ConstiTab 2 tablets after dinner). Symptom-related quality of life was assessed using patient-reported pain, discomfort, and defecation difficulty on a 1 to 10 Visual Analogue Scale, along with clinical signs including prolapse, oedema, and erythema. Results: All 87 patients completed the study, and no adverse events were reported. The regular treatment group showed slight improvement, with a significant reduction in sagging/prolapse after 6 and 8 weeks. The PiloKit group demonstrated significant improvement in all symptoms from baseline, including pain, itching, bleeding, constipation, erythema, and oedema (P < 0.05), while the placebo group showed no significant change. PiloKit was well tolerated, and most patients demonstrated clear clinical improvement. Conclusion: PiloKit significantly improved symptom severity and symptom-related quality-of-life measures without adverse effects. This formulation appears to be a safe, nonsurgical, and effective option for improving comfort and well-being in patients with anorectal disorders.
Keywords:
PiloKit
PiloSpray
PiloTab
ConstiTab
Haemorrhoids
Fissures
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